Safety and Efficacy of Pagibaximab Injection in Very Low... | NCT00646399

Studies
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis

NCT00646399

Sponsor

Biosynexus Incorporated

Status

Completed

Last Update Posted

Oct 24, 2011Estimated

Enrollment

1,579Actual

Phase

Phase 2Phase 3

Conditions

Staphylococcal Sepsis

Interventions

Placebo
Pagibaximab 50 mg/mL

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Mar 26, 2008

First Submission Date that Met QC Criteria

Mar 26, 2008

First Posted Date

Mar 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Aug 22, 2011

Results First Submitted that Met QC Criteria

Oct 20, 2011

Results First Posted Date

Oct 24, 2011Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2011

Last Update Posted Date

Oct 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

Detailed Description

Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,579Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Phosphate Buffered Saline	Drug: Placebo
Pagibaximab 50 mg/mL	Experimental	Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.	Drug: Pagibaximab 50 mg/mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.	Safety and efficacy	35 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In-patient at a Neonatal Intensive Care Unit (NICU)
Informed consent obtained from the legally authorized representative
Less than 48 hours old at the time of first infusion
Birth weight between 600 grams and 1200 grams
Estimated gestation age ≤33 weeks

For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.

Exclusion Criteria:

Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
Infants with proven staphylococcal infection prior to randomization.
Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
Immunodeficiency other than due to prematurity.
Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
Uncontrolled seizures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

48 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Biosynexus Incorporated		Gaithersburg	Maryland	20877	United States

ID	Title	Description
FG000	Pagibaximab
FG001	Placebo

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Pagibaximab
BG001	Placebo
BG002	Total

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous	Gestational Age

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.

Safety and efficacy

1579 very low birth weight subjects were included in the ITT.

Posted

Number

Participants

35 days

ID	Title	Description
OG000	Pagibaximab
OG001	Placebo

Units	Counts
Participants

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pagibaximab

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Necrotizing Colitis	Gastrointestinal disorders		Systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders		Systematic Assessment